MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS XT CHEMISTRY PRODUCTS GLU-CA SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number	6844295
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, lower than expected glucose (glu) result was obtained from a single patient sample processed using vitros chemistry products glu-ca xt slide lot: 7426-0023-8065 on a vitros xt7600 integrated system (s/n: (b)(6).The result was lower than expected compared to the results obtained for the same patient sample on two alternate vitros xt7600 systems at the customer site.A definitive assignable cause of the event could not be determined.Historical quality control results for vitros glu lot: 7426-0023-8065 showed inaccuracy and imprecision, therefore this reagent lot cannot be fully ruled out as a contributor to the event.However, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros glu reagent lot: 7426-0023-8065.The chu requested that the customer process a vitros alkp (alkaline phosphatase) precision test on the vitros xt7600 system that produced the lower-than-expected result to confirm the analyzer performance, however this was not completed at the time of this report.Therefore, an issue with the xt7600 integrated system cannot be fully ruled out as a contributor to the event.Pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not following the sample collection device manufacturers recommended centrifugation protocol.Improper pre-analytical sample handling could not be ruled out as a contributor to the event.A review of the pressure profiles of the individual patient sample runs confirmed that there was no indication that a pre-analytical patient sample mix-up occurred.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, lower than expected glucose (glu) result was obtained from a single patient sample processed using vitros chemistry products glu-ca xt slide lot: 7426-0023-8065 on a vitros xt7600 integrated system (s/n: (b)(6).The result was lower than expected compared to the results obtained for the same patient sample on two alternate vitros xt7600 systems at the customer site.Patient sample result of <20.0 mg/dl vs the expected result of 254.0 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower-than-expected vitros glu result was reported from the laboratory, and a corrected report was later issued for the result of 254.0 mg/dl.No treatment was altered, initiated or stopped based upon the initial reported result.There have been no reported allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).

• Brand Name: VITROS XT CHEMISTRY PRODUCTS GLU-CA SLIDES
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24046734
• Report Number: 1319809-2026-00001
• Device Sequence Number: 10022762
• Product Code: CGA
• UDI-Device Identifier: 10758750031795
• UDI-Public: (01)10758750031795(17)270301(11)250916(10)742600238065
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6844295
• Device Lot Number: 7426-0023-8065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown